Methods and Compositions for the Treatment of CNS-Related Conditions
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Abstract
The present invention provides novel methods and compositions for the treatment and prevention of CNS-related conditions. One of the CNS-related conditions treated by the methods and compositions of the invention is Alzheimer'"'"'s disease.
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Citations
58 Claims
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1-49. -49. (canceled)
- 50. A method of achieving improvement in cognition, behavior or activities of daily living in a patient with dementia within 12 weeks of initiation of memantine therapy comprising administering an acetylcholinesterase inhibitor (ACheI) and an extended release form of 10-100 mg of memantine or a pharmaceutically acceptable salt thereof and a component that sustains release of the memantine or salt thereof, wherein a therapeutically effective daily dose of the memantine or salt thereof is administered from initiation of therapy without prior dose escalation of memantine, and wherein the subject has a condition selected from the group consisting of Alzheimer'"'"'s disease, dementia, Parkinson'"'"'s disease, and neuropathic pain.
- 52. A method of achieving improvement in cognition, behavior or activities of daily living in a patient with dementia within 12 weeks of initiation of memantine therapy which comprises administering an acetylcholinesterase inhibitor (ACheI) and an extended release form of 10-100 mg of memantine or a pharmaceutically acceptable salt thereof and a component that sustains release of the memantine or salt thereof, wherein the memantine or salt thereof is administered to achieve a steady state plasma concentration of memantine within 20 days of initiation of therapy, and wherein the subject has a condition selected from the group consisting of Alzheimer'"'"'s disease, dementia, Parkinson'"'"'s disease, and neuropathic pain.
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54. A solid pharmaceutical composition in a unit dosage form for oral administration comprising a therapeutically effective amount of an extended release formulation of memantine or pharmaceutically acceptable salt thereof, wherein administration of a dose of the composition to a human subject provides a plasma memantine concentration profile characterized by a change in memantine concentration as a function of time (dC/dT) that is 50% less than that of an immediate release dosage form comprising the same dose of memantine as the composition, wherein the dC/dT is measured between the time period of 0 to Tmax of the immediate release form of memantine.
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55. A solid pharmaceutical composition in a unit dosage form for oral administration comprising a therapeutically effective amount of an extended release formulation of memantine or pharmaceutically acceptable salt thereof, wherein administration of a dose of the composition to a human subject provides a plasma memantine concentration profile characterized by a maximum memantine plasma concentration to mean memantine plasma concentration ratio (Cmax/Cmean) of about 2.5 to 2 at 1 hour to at least 6 hours after administration.
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56. A method of administering memantine and an acetylcholinesterase inhibitor (ACheI) to a human subject in need thereof, comprising:
- orally administering to the human subject once per day over multiple days a sustained release dosage form comprising 10-100 mg of memantine or a pharmaceutically acceptable salt thereof and a component that sustains release of the memantine or salt thereof, and the ACheI wherein a therapeutically effective daily dose of the memantine or salt thereof is administered from initiation of therapy without prior dose escalation of memantine, and wherein the subject has a condition selected from the group consisting of Alzheimer'"'"'s disease, dementia, Parkinson'"'"'s disease, and neuropathic pain.
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57. A method of administering memantine to a human subject in need thereof, comprising:
- orally administering to the human subject once per day over multiple days a sustained release oral dosage form comprising 10-100 mg of memantine or a pharmaceutically acceptable salt thereof and a component that sustains release of the memantine or salt thereof, wherein a therapeutically effective daily dose of the memantine or salt thereof is administered from initiation of therapy without prior dose escalation of memantine, and wherein the subject has a condition selected from the group consisting of Alzheimer'"'"'s disease, dementia, Parkinson'"'"'s disease, and neuropathic pain.
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58. A method of administering memantine and an acetylcholinesterase inhibitor (ACheI) to a human subject initiating memantine therapy, comprising:
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(i) administering an ACheI to the subject selected from the group consisting donepezil, rivastigmine, galantamine, tacrine, metrifonate, hupezine-A, and pharmaceutically acceptable salts thereof; and (ii) orally administering to the subject once daily over multiple days 5-40 mg memantine or a pharmaceutically acceptable salt thereof, wherein the memantine is in an extended release dosage form, wherein a therapeutically effective steady state plasma concentration of memantine is reached within twenty days from initiation of memantine therapy, and wherein the subject has a condition selected from the group consisting of Alzheimer'"'"'s disease, dementia, Parkinson'"'"'s disease, and neuropathic pain.
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Specification
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Current AssigneeAdamas Pharma, LLC (Supernus Pharmaceuticals, Inc.)
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Original AssigneeAdamas Pharmaceuticals, Inc. (Supernus Pharmaceuticals, Inc.)
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InventorsWent, Gregory T., Fultz, Timothy J.
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Granted Patent
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Time in Patent OfficeDays
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Field of Search
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US Class Current424/458
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CPC Class CodesA61K 2300/00 Mixtures or combinations of...A61K 31/13 Amines A61K31/04 takes prec...A61K 31/445 Non condensed piperidines, ...A61K 45/06 Mixtures of active ingredie...A61K 9/0053 Mouth and digestive tract, ...A61K 9/1635 obtained by reactions only ...A61K 9/1652 Polysaccharides, e.g. algin...A61K 9/20 Pills, tablets, discs, rods...A61K 9/2009 Inorganic compoundsA61K 9/2013 Organic compounds, e.g. pho...A61K 9/2054 Cellulose; Cellulose deriva...A61K 9/2059 Starch, including chemicall...A61K 9/2813 Inorganic compoundsA61K 9/282 Organic compounds, e.g. fatsA61K 9/48 Preparations in capsules, e...A61K 9/4808 characterised by the form o...A61K 9/7061 PolyacrylatesA61P 25/00 Drugs for disorders of the ...A61P 25/04 Centrally acting analgesics...A61P 25/16 Anti-Parkinson drugsView All
